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[QUOTE=Unregistered;297614][b][u]Students Name [/u][/b]: Mrs. Bijal Jani 
[b][u]E-mail  [/u][/b]: bijal_pandya2003 AT yahoo.com

[b][u]Personal Data [/u][/b]:
[b][u]Date of Birth  [/u][/b]: sept. 30, 1988
[b][u]Sex  [/u][/b]: 
[b][u]Nationality  [/u][/b]: Indian
[b][u]Marital Status [/u][/b]: Married
[b][u]Languages Known [/u][/b]: English, Hindi, Gujarati.

[b][u]Career Objective [/u][/b]:
To obtain a suitable position in a corporate organization, where my skills and knowledge will help me attain excellence and where the opportunities provided will lead to avenues for professional and personal growth.
To be recognized as a dedicated, quality oriented team leader, who can perform duties entrusted as per the profile designated and work with full determination to achieve results.

[b][u]Clinical research knowledge [/u][/b]:
[b][u]Clinical research [/u][/b]: 
** Phases of CR, Ethics committee and IRB
** ICH GCP, Indian GCP, ICMR, Schedule Y
** IND, NDA, Informed consent process, subject selection
** Drug discovery and development
** Clinical trial design
** Sponsor, Investigator, Vendor responsibilities
** Site selection, initiation, close out, contract, budget
** Protocol design, SOPs, CSR, CRF design, review and SDV
** Site monitoring, Audit, Inspection

[b][u]Pharmacovigilance [/u][/b]:
** Expedited reporting requirements
** Regulatory aspects of PV, QA in PV
** ICSR case processing, Risk management, Medical evaluation of AEs Signal detection, PV database
** Signal detection, PV database
** PSUR, MedDRA, Narrative writing
** SAEs forms

[b][u]Professional Qualification [/u][/b]:
[b][u]Academic Credentials University Aggregate  [/u][/b]:
PGDCRPV(Post Graduate Diploma in Clinical Research & Pharmacovigilance ) Cliniminds, Ahmedabad completed 
Basic Qualification
Bachelor of pharmacy Rajeev Gandhi University ,Bangalore 60%completed

[b][u]Practical Hands-on [/u][/b]: 
** Protocol designing
** Preparing Clinical Study Report (CSR)
** Preparing Case Report Form(CRF)
** Preparing SAEs(Serious Adverse Event) Form

[b][u]Technical Skills [/u][/b]: 
** MS Office. 
** Internet.

[b][u]Strengths [/u][/b]: 
** Dedication
** Confident
** Hardworking
** Good team work
** Sincere
** Co-operative & goal oriented person
** Ability to work & thrive under pressure
** Eagar to know about new things & share to other
 
[b][u]Declaration [/u][/b]:
I hereby declare that the information given above is genuine to the best of my knowledge & if you give an opportunity to work in your organization, I will put my best efforts.
[b][u]Place [/u][/b]: Ahmedabad
[b][u]Date [/u][/b]: 11 /02/14 
(Mrs. Bijal Jani)[/QUOTE]

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